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Active Not RecruitingNCT06307704

Lung US for PEEP Optimization in Robotic Radical Prostatectomy or Cystectomy Patients

Intraoperative Bedside Lung-ultrasound Use to Optimize Positive End-expiratory Pressure for Elective Robotic-assisted Radical Prostatectomy or Cystectomy Patients: a Randomized Controlled Trial

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
88 (estimated)
Sponsor
Nazmy Edward Seif · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

Summary

There is an increasing trend in the use of robotic-assisted radical prostatectomy or cystectomy (RARPC). Preventing lung atelectasis without inducing overdistention of the lung is challenging. Many studies tried to optimize PEEP titration by using methods such as dead space fraction guided and static pulmonary compliance directed techniques, or by using electrical impedance tomography. However, the use of these methods is limited by inaccuracy and the need for sophisticated devices. Bedside Lung ultrasound is fast, easy and economic technique that is gaining interest in the operating room. Ultrasound-guided PEEP titration has been used in bariatric surgeries (different position and usually shorter procedure time) and proved effective in improving oxygenation, compliance and reducing the incidence of postoperative pulmonary atelectasis and hypoxia without causing hemodynamic instability. The aim of this study is to evaluate the effectiveness of intraoperative individualized lung ultrasound-guided stepwise PEEP optimization in patients undergoing RARPC on oxygenation, intraoperative and early postoperative pulmonary complications.

Conditions

Interventions

TypeNameDescription
PROCEDURELung Ultrasound - guided Stepwise PEEPAfter endo-tracheal intubation; A PEEP of 4 cmH2O will be initially used till 5 min after pneumoperitoneum. Then The PEEP will be adjusted in a stepwise approach after performing bedside lung ultrasound. The PEEP will be increased by 2 cmH2O until no lung collapse is detected. Lung ultrasound will be repeated 5 min after every change in the PEEP with a maximal PEEP of 12 cmH2O.
PROCEDUREStandard Ventilation ProtocolVolume-controlled ventilation (VCV) mode; with a tidal volume of 6 mL/kg of ideal weight, inspiratory : expiratory ratio 1: 2, PEEP 4 cmH2O, respiratory rate adjusted to keep end-tidal carbon dioxide tension (EtCO2) between 35 and 40 mm Hg, and inspired oxygen fraction of 50%.

Timeline

Start date
2024-04-01
Primary completion
2026-04-01
Completion
2026-04-01
First posted
2024-03-13
Last updated
2026-03-18

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT06307704. Inclusion in this directory is not an endorsement.